Calquence

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acalabrutinib

Authorised
This medicine is authorised for use in the European Union.

Overview

Calquence is a cancer medicine used to treat adults with chronic lymphocytic leukaemia (CLL), a blood cancer affecting B cells (a type of white blood cell).

Calquence is used on its own (monotherapy) in patients with CLL who have had previous treatment. In patients who have not had previous treatment for the condition, Calquence may be used on its own or combined with another cancer medicine, obinutuzumab.

Calquence contains the active substance acalabrutinib.

This EPAR was last updated on 11/11/2020

Authorisation details

Product details
Name
Calquence
Agency product number
EMEA/H/C/005299
Active substance
Acalabrutinib
International non-proprietary name (INN) or common name
acalabrutinib
Therapeutic area (MeSH)
Leukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code
L01XE51
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
AstraZeneca AB
Date of issue of marketing authorisation valid throughout the European Union
05/11/2020
Contact address

SE-151-85 Sodertalje
Sweden

Product information

05/11/2020 Calquence - EMEA/H/C/005299 -

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Pharmacotherapeutic group

Antineoplastic agents, protein kinase inhibitors

Therapeutic indication

Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

Assessment history

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